Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Drug: Tranexamic Acid (TXA)Drug: Normal saline
- Registration Number
- NCT06330935
- Lead Sponsor
- Mansoura University
- Brief Summary
Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Age Less than 18 years old
- Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan
- Time of admission within 3 hour of injury.
- Patient Known pregnancy.
- patient had Cardiac arrest prior to randomization
- GCS score of 3 with bilateral unresponsive pupils
- Known bleeding/clotting disorders.
- Known seizure disorders.
- Known history of severe renal impairment
- Unknown time of injury
- Prior TXA for current injury
- Known venous or arterial thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TXA dose A arm Tranexamic Acid (TXA) Subjects will receive a 15 mg/kg bolus of Tranexamic acid over 20 minutes followed by 2 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 1000 mg, the maximum rate of infusion is 50 mg/min, and the maximum total maintenance dose is 1000 mg TXA dose B arm Tranexamic Acid (TXA) Subjects will receive a 30 mg/kg bolus of Tranexamic acid over 20 minutes followed by 4 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 2000 mg, the maximum rate of infusion is 100 mg/min, and the maximum total maintenance dose is 2000 mg Placebo arm C Normal saline Subjects in the placebo group will receive a bolus dose of normal saline over 20 minutes followed by a normal saline infusion over 8 hours (in the same weight-based volume as the other study arms)
- Primary Outcome Measures
Name Time Method The early traumatic brain injury-related death in the hospital 24 hour and 48 hour after injury 2. Decreasing the rate of early head injury-related death (within 24 hour after injury)
The difference between treatment group in the Intracranial haemorrhage growth 24 hour We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan
The difference between the treatment groups in the incidence of mortality 28 days Decreasing the rate of head injury-related death in hospital within 28 days of injury all-cause and cause-specific mortality, disability, vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism)
- Secondary Outcome Measures
Name Time Method Adverse events 28 days Decreasing incidence of seizures, complications and other adverse events
Need for neurosurgical management 28 day Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)
Days in the intensive care unit 28 day Decreasing days in intensive care unit within 28 day of injury
Need for blood transfusion 48 hour Decreasing the total amount of blood products transfused in the initial 48 hours following randomization. Blood product transfusion volume will be measured at 24 hours, 48 hours. This will include volume of packed red blood cells, plasma, platelets, and cryoprecipitate in mL/kg.
Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) 6 months Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores
Pediatric Quality of Life (PedsQL) 6 months Improving the Paediatric Quality of Life (PedsQL) . The PedsQL is a continuous score that ranges from 0-100.
Trial Locations
- Locations (1)
Al-Azhar University Hospital in New Damietta
🇪🇬Damietta, Egypt